MAUDE Adverse Event Report: K2M, INC. POLYAXIAL SCREW ML; SIZE Ø5.0X30 MM; POSTERIOR CERVICAL SCREW SYSTEM

Model Number	7601-05030M-G1
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.A supplemental vmsr will be submitted upon completion of the investigation.
Event or Problem Description
This report summarizes one malfunction event where a yukon oct polyaxial screw broke while being redirected into a new path.The screw shaft was retrieved and surgery was successfully completed with another screw and a 5 minute delay.No adverse consequences or medical intervention were reported.
Additional Manufacturer Narrative
This mdr is part of the fda voluntary malfunction summary reporting program.Visual inspection: the device was inspected, and it was observed that the screw had fractured immediately below the ball feature of the screw shank.Abrasions were also observed on the proximal end of the screw shank.Complaint history records were reviewed for this lot, and no similar complaints were identified.According to the rep, the surgeon did tap line to line but seemed to be over-torquing the screw during insertion.Additionally, analysis of the fracture face suggests that the failure occurred in torsion.Root cause of event is over-torquing.
Event or Problem Description
This report summarizes one malfunction event where a yukon oct polyaxial screw broke while being redirected into a new path.The screw shaft was retrieved and surgery was successfully completed with another screw and a 5 minute delay.No adverse consequences or medical intervention were reported.

• Brand Name: POLYAXIAL SCREW ML; SIZE Ø5.0X30 MM
• Common Device Name: POSTERIOR CERVICAL SCREW SYSTEM
• Manufacturer (Section D): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer (Section G): K2M, INC.; 600 hope parkway se; leesburg VA 20175
• Manufacturer Contact: rita karan ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 12721080
• Report Number: 3004774118-2021-00331
• Device Sequence Number: 1364107
• Product Code: NKG
• UDI-Device Identifier: 10888857395831
• UDI-Public: 10888857395831
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K171444
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 7601-05030M-G1
• Device Catalogue Number: 7601-05030M-G1
• Device Lot Number: NAPD
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 01/01/2022
• Initial Report FDA Received Date: 10/29/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown